ANMAT
The article provides an overview of the new regulation and highlights the key points associated thereto.
BfArM
The new article highlights the aspects related to the temporary and permanent admission of digital health applications. Table of Contents The German regulating authority in the sphere of healthcare products, the Federal Institute for Drugs and Medical Devices...
Canada
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
CDRH
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
